Last week the FDA approved yet another uber expensive therapy, Evkeeza from Regeneron Pharmaceuticals, to treat homozygous familial hypercholesterolemia (HoFH), an ultra-rare inherited condition that affects approximately 1,300 patients in the U.S. and is characterized by extremely high low-density lipoprotein cholesterol (LDL-C)
Evkeeza is an infused therapy and is weight based. The recommended dosing regimen of Evkeeza is 15 mg per kilogram of body weight every 4 weeks. Evkeeza was also granted a pediatric indication and can be combined with other lipid lowering therapies. Evkeeza is the first FDA approved treatment that binds to and blocks the function of angiopoietin-like 3 (ANGPTL3), a protein that plays a key role in lipid metabolism.
Wholesale Acquisition Cost (WAC) per patient in the U.S. will vary based on weight and is expected to be approximately $450,000 per year on average.
Orsini Specialty Pharmacy, a leader in rare diseases and gene therapies, has announced that it has been selected by Regeneron Pharmaceuticals as the exclusive specialty pharmacy partner for Evkeeza. Product will be shipped direct to the treating physician office, another example of a limited distribution – direct-to-office (LD-DTO) program. Orsini will also provide HUB services including product information, insurance benefit verification, community resources and appointment reminders.
FDA Approves First-in-class Evkeeza for Patients with Ultra-rare Inherited Form of High Cholesterol
Feb. 11, 2021 /PRNewswire/ — Homozygous familial hypercholesterolemia (HoFH) is an ultra-rare inherited condition that affects approximately 1,300 patients in the U.S. and is characterized by extremely high low-density lipoprotein cholesterol (LDL-C)
In pivotal Phase 3 HoFH trial, adding Evkeeza to standard lipid-lowering therapies reduced LDL-C by nearly half at 24 weeks, compared to placebo
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) approved EvkeezaTM (evinacumab-dgnb) as an adjunct to other low-density lipoprotein cholesterol (LDL-C) lowering therapies to treat adult and pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH). Evkeeza is the first FDA-approved treatment that binds to and blocks the function of angiopoietin-like 3 (ANGPTL3), a protein that plays a key role in lipid metabolism.
“The FDA’s approval of Evkeeza is a watershed moment…………
CLICK HERE TO READ THE FULL PRESS RELEASE
